Coronary Bypass Marker 10-696

GUDID B776106961

Suturing Washer

FIRST CALL, INC.

Metallic coronary bypass marker, non-sterile

• Primary Device ID: B776106961
• NIH Device Record Key: 3aee9866-a13e-4c4d-b860-8e3fe3868d13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coronary Bypass Marker
• Version Model Number: Rev1
• Catalog Number: 10-696
• Company DUNS: 015526185
• Company Name: FIRST CALL, INC.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B776106961 [Primary]
HIBCC	B7761069619 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052642

FDA Product Code

• MAB: Marker, Cardiopulmonary Bypass (Vein Marker)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B776106961]

Moist Heat or Steam Sterilization

[B776106961]

Moist Heat or Steam Sterilization

[B776106961]

Moist Heat or Steam Sterilization

[B776106961]

Moist Heat or Steam Sterilization

[B776106961]

Moist Heat or Steam Sterilization

[B776106961]

Moist Heat or Steam Sterilization

[B776106961]

Moist Heat or Steam Sterilization

[B776106961]

Moist Heat or Steam Sterilization

[B776106961]

Moist Heat or Steam Sterilization

[B776106961]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-11
• Device Publish Date: 2019-10-03